Clinical trial · Interventional
Haploidentical Natural Killer Cells to Treat Refractory or Relapsed Acute Myelogenous Leukemia (AML)
Adoptive Transfer of Haploidentical Natural Killer Cells to Treat Refractory or Relapsed AML MT2010-02
NCT01106950CI-TRIAL-00030936terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): study drug (Ontak) no longer available
Summary
Brief summary (as posted)
This is a phase II therapeutic study of related donor HLA-haploidentical NK-cell based therapy after a high dose of fludarabine/cyclophosphamide with denileukin diftitox preparative regimen for the treatment of poor prognosis acute myelogenous leukemia (AML).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myelogenous, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Denileukin diftitox | Drug | — | UNRESOLVED |
| Donor lymphapheresis | Procedure | — | UNRESOLVED |
| Fludarabine | Drug | Fludarabine | ALIAS |
| IL-2 | Drug | — | UNRESOLVED |
| Natural Killer Cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treated Patients
- description
- Patients are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
- interventionNames
- Biological: Natural Killer Cells
- Drug: Fludarabine
- Drug: Cyclophosphamide
- Drug: Denileukin diftitox
- Procedure: Donor lymphapheresis
- Drug: IL-2
Primary outcomes (1)
- measure
- Percent of Patients With Successful Expansion of Natural Killer Cells After Infusion
- timeFrame
- Day 14
- description
- The primary objective of this study was to estimate the incidence of in vivo expansion of natural killer (NK) cells 14 days after infusion of an allogeneic donor product enriched for NK progenitors. Successful in vivo donor NK cell expansion was defined by measuring an absolute circulating donor-derived NK cell count of \>100 cells/ul in the patient's peripheral blood 14 days after infusion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
Inclusion Criteria:
* ≥ 2 years of age
* Meets one of the following disease criteria:
* Primary acute myelogenous leukemia (AML) induction failure: no complete remission (CR) after 2 or more induction attempts
* Relapsed acute myelogenous leukemia (AML): not in CR after 1 or more cycles of standard re-induction therapy. For patients \> 60 years of age the 1 cycle of standard chemotherapy is not required if either of the following criteria is met:
* relapse within 6 months of last chemotherapy
* blast count \< 30% within 10 days of starting protocol therapy
* Secondary AML from myelodysplastic syndrome (MDS)
* AML relapsed \> 2 months after transplant who do not have the option of donor lymphocyte infusions (e.g. recipients of autologous or umbilical cord blood \[UCB\] transplants) Patients with prior central nervous system (CNS) involvement are eligible provided that it has been treated and CSF is clear for at least 2 weeks or magnetic resonance imaging (MRI) stable prior to enrollment. CNS therapy (chemotherapy or radiation) should continue as medically indicated during the study treatment.
* Available related HLA-haploidentical donor (3-5 of 6 HLA-A, B and C)
* Karnofsky Performance Status \> 50% or Lansky Play score \> 50
* Adequate organ function defined as:
* Creatinine: ≤ 2.0 mg/dL (for pediatric patients - ClCr \> 50 ml/min or age adjusted Cr)
* Hepatic: Liver function tests (LFT's) \< 5 x upper limit of institutional normal (ULN)
* Pulmonary Function: oxygen saturation ≥ 90% on room air and pulmonary function \>50% corrected Diffusion lung capacity for carbon monoxide (DLCO) and Forced expiratory volume in one second (FEV1) Oxygen saturation \[\>92%\] can be used in child where pulmonary function tests (PFT's) cannot be obtained. (Testing required only if symptomatic or prior known impairment.)
* Cardiac Function: Ejection fraction (EF) ≥ 40%, no uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
* Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to natural killer (NK) cell infusion (excluding denileukin diftitox pre-meds)
* Women of child bearing potential must have a negative pregnancy test within 14 days prior to study registration and agree to use adequate birth control during study treatment.
* Voluntary written consent
Exclusion Criteria:
* Bi-phenotypic acute leukemia
* Transplant \< 60 days prior to study enrollment
* New or progressive pulmonary infiltrates on screening chest x-ray or chest computated tomography (CT) scan that has not been evaluated with bronchoscopy, if feasible. Infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections). Surgical resection waives any waiting requirements.
* Uncontrolled bacterial or viral infections - chronic asymptomatic viral hepatitis is allowed
* Pleural effusion large enough to be detectable on chest x-ray
* Known hypersensitivity to any of the study agents used
* Received investigational drugs within the 14 days before enrollment
* Known active CNS involvementReferences
Publications (1)
- DERIVEDBachanova V, Cooley S, Defor TE, Verneris MR, Zhang B, McKenna DH, Curtsinger J, Panoskaltsis-Mortari A, Lewis D, Hippen K, McGlave P, Weisdorf DJ, Blazar BR, Miller JS. Clearance of acute myeloid leukemia by haploidentical natural killer cells is improved using IL-2 diphtheria toxin fusion protein. Blood. 2014 Jun 19;123(25):3855-63. doi: 10.1182/blood-2013-10-532531. Epub 2014 Apr 9. PMID 24719405